Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.
Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.
We are looking for highly motivated and enthusiastic individuals who are interested to be part of our Clinical Operations Team.
Senior Clinical Project Specialist
Regulatory Affairs & Clinical Data Management Director
Overview of the role
This individual will be part of the Clinical Operations team and requires a solid understanding of trial and data management, and of the company’s clinical trials to provide key updates and metrics to guide the management of the trials.
- Liaise with CROs and third party vendors to ensure studies are performed in compliance with study protocol, local regulations and IRB requirements; identify areas of concern and escalate as necessary.
- Support in generation of study documents such as clinical protocols, amendments, informed consent forms, and other clinical research related documents.
- Prepare Regulatory dossiers for consultation meetings and applications.
- Maintain and update internal study trackers.
- Generate and track key study milestone and quality metrics for internal stakeholder review and suggest appropriate actions for improvement or rectification
- Maintains sponsor trial and department documents
- Coordinate site contract reviews between relevant stakeholders
- Review and reconciliation of vendor invoices against Work Done Reports
- Participate in periodic review of data in EDC
- Generate periodic clinical data management reports and metrices, such as but not limited to data entry reports and query resolution reports
- Preparation and review of study/template Case Report Forms (CRF) and Completion Guidelines
- Address site queries regarding clinical data and escalate as necessary
- Perform periodic review of Edit Check Specifications
- Bachelor’s Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
- At least 3 years’ experience working in clinical research
- Interest in immuno-oncology drug development an advantage
- Proficiency in MS Excel required, programming knowledge an advantage